Clinical trials: Maximum Tolerated Dose
Colorectal Cancer (CRC), Gastric Cancer
A Study of SC-007 in Subjects With Advanced Cancer
This is a multicenter, open-label, Phase 1 study in participants with colorectal cancer (CRC) or gastric cancer to study the safety and tolerability of SC-007 and consists of Part A (dose regimen finding) in participants with CRC…
- Trial name
- NCT03253185
- Testing
- SC-007
- Where
- 7 sites in United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- AbbVie
Healthy
First-in-human Study to Evaluate Safety, Tolerability and Pharmacokinetics of Various Doses of BCD-085 in Healthy Subjects
This is an open label, phase 1, "3+3" dose escalating study of tolerability, safety, pharmacokinetics and immunogenicity of a single subcutaneous injection of the novel monoclonal antibody against human IL-17 - BCD-085.
- Trial name
- NCT02380287
- Testing
- humanized monoclonal antibody against human IL-17
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Biocad
Amyotrophic Lateral Sclerosis
To Determine the Maximum Tolerated Dose (MTD) of HK-001 in Healthy Volunteers
Eligible subjects will receive either different dosages of HK-001 or placebo in a 3:1 ratio in 1 of the 7 dose cohorts. After single dose administration, followed by an independent Data and Safety Monitoring Board (DSMB) meeting…
- Trial name
- NCT03651349
- Testing
- HK-001
- Where
- Taiwan
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Everfront Biotech Co., Ltd.
Healthy
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ESR 1150 CL in Healthy Subjects
The objective of this study was to obtain safety and tolerability data and first pharmacokinetic and pharmacodynamic data of escalating doses of ESR 1150 CL.
- Trial name
- NCT02209688
- Testing
- ESR 1150 CL
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Maximum Tolerated Dose, Dose Escalation
Study to Evaluate the Safety and Tolerability of AD-NP1 in Healthy Human Adult Volunteers
This is a Phase 1 single-blind, placebo-controlled, dose-escalation study designed to evaluate the safety of AD-NP1, a humanized monoclonal antibody targeting human ectonucleotide pyrophosphatase/phosphodiesterase-1 (ENPP1).
- Trial name
- NCT07762001
- Testing
- AD-NP1
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Arjun Deb, MD
Healthy Subjects, Pharmacokinetics of ASP6294
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP6294 Administered Intravenously or Subcutaneously in Healthy Young Male and Female Subjects
The purpose of this study is to evaluate the safety and tolerability of single ascending intravenous doses and single subcutaneous (sc) doses of ASP6294 in healthy young male and female subjects.
- Trial name
- NCT02681861
- Testing
- ASP6294 Intravenous, ASP6294 Subcutaneous
- Where
- United Kingdom
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Healthy Male
Determining Highest Dose Administration of TC-5214 and Evaluating Effect on the Electrical Activity in the Heart
This is a two part study. Part A will determine the maximum tolerated dose of TC-5214 administered to healthy male subjects in single ascending oral doses.
- Trial name
- NCT01359618
- Testing
- TC-5214, Moxifloxacin
- Where
- United Kingdom
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy Volunteer
Study to Assess the Safety and Pharmacokinetics of WP1122 in Healthy Volunteers
This study in healthy human volunteers will investigate the effects of a single dose (SAD) and multiple days of dosing (MAD) of WP1122 administered as an oral (PO) solution.
- Trial name
- NCT05195723
- Testing
- WP1122
- Where
- United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Moleculin Biotech, Inc.
PAH
Dose Escalation, MTD, Safety and PK Study of a Single Dose SC Injection of TransCon PEG Treprostinil in Healthy Male Volunteers
TransCon PEG treprostinil is a novel prodrug form of treprostinil, in which treprostinil is reversibly conjugated via a four-arm branched polyethylene glycol (PEG) molecule.
- Trial name
- NCT02149095
- Testing
- TransCon PEG treprostinil
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- United Therapeutics
Healthy Volunteer Subjects
A Study to Establish Safety and Maximum Tolerated Dose of IV Trehalose in Healthy Subjects
This will be a double-blind, randomized, placebo-controlled, single ascending dose study performed in healthy subjects. The study will include up to four escalating dose cohorts with eight (8) subjects in each cohort.
- Trial name
- NCT02725957
- Testing
- Trehalose for IV Infusion, Saline 0.9% IV
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bioblast Pharma Ltd.
Opiate Withdrawal Syndrome
A Study of Oral Ibogaine in Opioid Withdrawal
Study DMX-IB 201 is a Phase 1/2a study of ibogaine consisting of an initial single ascending dose escalation stage to determine the maximum tolerated dose (MTD) or treat-to-target dose (TTD) in healthy volunteers, followed by a…
- Trial name
- NCT05029401
- Testing
- DMX-1002
- Where
- 2 sites in United Kingdom
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- atai Therapeutics, Inc.
Knee Osteoarthritis, Umbilical Cord Bleeding
The Maximum Tolerated Dose of Mesenchymal Stem Cells From Umbilical Cord
The aim of this study was to evaluate the maximum tolerated dose of Mesenchymal Stem Cells (MSCs) from umbilical cord in the treatment of human knee OA
- Trial name
- NCT03357770
- Testing
- mesenchymal stem cells
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Peking University People's Hospital
RSV Infection
ALX-0171 Phase I Study, Evaluating Single Ascending Dose and Multiple Dose in Healthy Male Volunteers
ALX-0171 is a Nanobody directed against the human respiratory syncytial virus (RSV). The purpose of this first-in-man study is to determine the safety, tolerability and pharmacokinetics (PK) of ALX-0171 after single and multiple…
- Trial name
- NCT01483911
- Testing
- ALX-0171
- Where
- Netherlands
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Ablynx, a Sanofi company
Pharmacokinetics of ASP1707, Pharmacodynamics of ASP1707
A Study to Assess the Safety, Tolerability and Effects of Single and Multiple Ascending Doses of ASP1707 in Healthy Male and Pre-menopausal Female Subjects, Including a Comparison of the Effects Under Fasted and Fed Conditions in Healthy Young Male Subjects
This study consists of four parts: Part 1 is a randomized, double-blind, placebo-controlled, single ascending dose study in healthy young male subjects to evaluate the safety, tolerability pharmacokinetics (PK) and effect on…
- Trial name
- NCT02368912
- Testing
- ASP1707 single dose of dose levels 1 -7, ASP1707 single dose fasted, ASP1707 single dose fed
- Where
- France
- Volunteers
- 176 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Schizophrenia
A Phase I- Sequential Cohort Dosing to Determine Maximum Tolerated Dose in Healthy Male Volunteers.
This is a prospective, 8-day, randomized, double-blind, placebo-controlled, sequential-cohort study designed to evaluate the safety, tolerability, and MTD of single escalating oral doses of NW-3509A in healthy male volunteers.
- Trial name
- NCT01955564
- Testing
- NW-3509a
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Newron Pharmaceuticals SPA
Malaria
A Dose-escalation Study to Investigate Safety and Toleration of OZ439
A randomised, placebo-controlled, dose-escalation study to investigate safety and toleration of OZ439 OD for 3 days to healthy male and female volunteers.
- Trial name
- NCT01713608
- Testing
- OZ439
- Where
- United Kingdom
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
Healthy Subjects, Pharmacokinetics of ASP015K
A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP015K
The objective of the study is to explore safety and tolerability of single ascending doses of ASP015K, establish the maximum tolerated dose, and determine the pharmacokinetics and pharmacodynamics in healthy volunteers.
- Trial name
- NCT01387087
- Testing
- ASP015K
- Where
- 2 sites in United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Multiple Myeloma, Refractory
Anti-BCMA CAR-NK Therapy in Relapsed or Refractory Multiple Myeloma
Immunotherapy has shown promise in the treatment of hematological malignancies, including multiple myeloma. One approach is CAR-NK cell therapy, which involves genetically modifying natural killer (NK) cells to target specific…
- Trial name
- NCT06242249
- Testing
- Anti-BCMA CAR-NK
- Where
- Iran
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Shahid Beheshti University of Medical Sciences
Fetal Alcohol Spectrum Disorders
Dose Escalation Study of Vinpocetine in Healthy Volunteers
The objective of this study is to determine whether vinpocetine is safe when taken at higher doses.
- Trial name
- NCT06635746
- Testing
- Vinpocetine
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Stanford University
Pharmacokinetics of ASP8477, Pharmacodynamics of ASP8477
A Study to Assess the Effects of Single Ascending Doses (SAD) of ASP8477, the Effect That Food Has on the Drug, and the Interaction Between ASP8477 and Omeprazole in Healthy Postmenopausal Females and Healthy Young Vasectomized Males
This is a 4-part study. Part I assesses the safety and tolerability of single ascending doses of ASP8477 or a placebo under fasted conditions in postmenopausal subjects.
- Trial name
- NCT02220777
- Testing
- ASP8477, omeprazole
- Where
- 2 sites in Belgium, France
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.